Qualified Person

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Qualified Person (QP) will have overall responsibility for the QP certification of Drug Product and Intermediates in accordance with UK Code of Conduct for Qualified Persons, and acting as a point of contact for queries relating to QP certification and batch release.

Key responsibilities

• Undertakes the duties of a Qualified Person as defined in Directives 2001/82/EC.
• Responsible for the QP certification of Drug Product and Intermediates in accordance with UK Code of Conduct for Qualified Persons, acting as a point of contact for queries relating to QP certification and batch release.
• Working with the Quality Compliance Manager to provide an efficient and effective service to support the timely release of materials, components and products including UK Commercial and imported products controlled by the sites.
• Working with the site management, ensureing that the UK sites operate in a fully GMP compliant manner in accordance with all of the relevant legislation, corporate governance requirements (including reporting), policies, procedures and guidelines as well as ensuring that the products and processes are fully compliant with the filed regulatory dossiers for the products supported.
• Working with the Quality Systems Manager ensuring that the Quality Management System (QMS) is fit for purpose, as far as practicable harmonized across the sites and in compliance with global policies.
• Engage in self inspection of the site QMS.
• Act as a GMP Subject Matter Expert (SME) to facilitate site compliance with the company’s Pharmaceutical Quality System. Mentor others to expand on-site compliance knowledge.
• Supporting senior QA leadership through QP decision making to drive continuous improvement and ‘fitness for purpose’
• Partners with and supports other sites and functions as needed during the technical transfer of products into and out of the site
• Partners proactively with other sites within the supply chain to ensure that products and intermediates are received, released and shipped in a timely and fully GxP compliant manner.
• Acts as the point of focus for all compliance inspections of the sites e.g. internal and corporate audits as well as Regulatory Inspections
• Either directly or through colleagues, liaises with the Veterinary Medicines Directorate (VMD) regarding the routine release of biological products and at other times to secure the resolution of complaints and other issues that might impact the quality and supply of the products supplied by or for the company.
• The candidate will also manage some of the improvements projects within the Quality Control Department to align to current GLP.

Qualifications, Skills & Experience Required

• Degree in Pharmacy, Chemistry, Biology or relevant biosciences discipline.
• Eligible for nomination as a Qualified Person.
• Experience in performing EU Qualified Person batch certification.
• Experience of Sterile Product Pharmacuetical manufacturing QA is desirable but not essential.
• 5 years post graduate experience in pharmaceutical manufacturing either in a QA or QC role.
• Supervisory or management experience desirable
• Auditing experience desirable
• Proven technical ability including: knowledge of GMP/GCLPs, QMS, test method validation & equipment qualification, continuous improvement/business excellence and Lean and 6 Sigma is desirable
• Excellent interpersonal skills including good communication, conflict management and leadership
• Excellent decision-making and problem solving skills.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R212248